Carrie A. Leach
Director Of Quality Management Systems
Attica,IN
The opposite of a true statement is a false statement, but the opposite of a profound truth may well be another profound truth.
Niels Bohr
Summary
Strategic, organized Director of Quality Management Systems with 20+ years of experience overseeing quality control, process improvement, and regulatory compliance in biotechnology and pharmaceutical industries. Skilled in developing and implementing quality systems, leading cross-functional teams, and driving continuous improvement initiatives. Proven ability to ensure compliance with industry standards and regulations, including ISO, FDA, EPA, USDA and DEA requirements. Excellent leadership and communication skills integrated with analytical abilities to determine areas for potential improvement.
Overview
25
25
years of professional experience
4
4
years of post-secondary education
Work History
Director of Quality Management Systems
Inari
West Lafayette, IN
05.2021 - Current
- Oversee global QMS implementation spanning three sites and two countries at biotechnology start-up setting priorities in alignment with strategic vision
- Collaborate with team leads and SMEs to implement parts of QMS in product lifecycle
- Write, revise, and implement standard operating procedures and test methods
- Establish eQMS for company
- Routinely provide progress report to executive management
- Lead global team of cross-functional stake holders to implement all QMS continuous improvement tools
- Successfully established controls to mitigate risk in all sections of product development
- Globally implement ISO9001 standards and collaborate with EH&S manager to implement ISO45001
- Collaborate with regulatory function leads for federal submissions
- Demonstrated respect, friendliness and willingness to help wherever needed
- Demonstrated creativity and resourcefulness through development of innovative solutions
- Demonstrated leadership skills in managing projects from concept to completion
- Organized and detail-oriented with astrong work ethic
Quality Assurance Director
Office of Indiana State Chemist, Purdue University
West Lafayette, IN
08.2013 - 04.2021
- Directed implementation of eQMS for agency and implemented LIMS for laboratory
- Supported application of hemp pesticide, and fertilizer, licensing software and feed tonnage receiving and reporting software
- Created, revised, and established standard operating procedures and test methods
- Designed and create policy for Office of Indiana State Chemist (OISC) agency
- Oversaw quality assurance for entire office and adherence of safety Purdue standards as safety officer
- Directed laboratories in adoption of ISO 17025:2017 standards
- Conducted duties as designated Ethics Office with Office of Inspector General
- Administered adherence of feed program to FDA Animal Feed Regulatory Program Standards
- Facilitated coordination of program needs and laboratory requirements
- Approved laboratories as cooperator laboratories for testing TCH in hemp through external auditing
- Supervised program activities
- Spearheaded growth of quality assurance department by 400% and implemented process improvement tools
- Orchestrated internal audits and improved sample quality of incoming samples
- Chair national committee and collaborate with federal partners including EPA, FDA, DEA and USDA
- Implement ISO9001 and ISO17025 standards
- Maintain Quality Management Program/Quality Assurance Project Program documents throughout their lifecycle
- Establish quality goals for agency in EPA Region 5 cooperative agreement
- EH&S officer for agency
- Enforced compliance with government regulations and company policies
- Oversaw QA operational activities such as sampling, inspection and line monitoring, verifying compliance with prescribed fault rates and tolerance goals
Quality Assurance Manager
SSCI, Inc
West Lafayette, IN
04.2004 - 08.2013
- Supervised team and participated in external client, subcontractor, and other vendor audits and pharmaceutical CRO
- Directed FDA (21 CFR Part 211 and 21 CFR Part 11) and DEA (Schedule I-V) audits annually
- Wrote, revised, and implemented standard operating procedures and test methods
- Assessed cGMP compliance in internal audits and audited scientific reports in comparison to company procedures
- Approved certificate of analyses for lot release and batch release and conducted company-wide cGMP training sessions
- Organized cGMP training sessions for new employees
- Coordinated global harmonization of computer software validation
- Reviewed and approved computer software validation activities in line with GAMP5 and 21 CFR part 11
- Facilitated FDA audits which resulted in no 483 findings
- Lead computer systems validation of all in-house software applications
- Added value to current quality systems with consistent career growth through promotion and increased responsibilities.
Technical Writer
Eli Lily & Co
Indianapolis, IN
10.2003 - 03.2004
- Increased quality control metrics by working with 15 subject matter experts writing SOPS and technical documents for metrology laboratory and software applications.
- Proved successful working within tight deadlines and a fast-paced environment
Quality Systems Specialist
Abbott Laboratories
Chicago, IL
02.2000 - 07.2003
- Solved complex quality issues with use of 6 Sigma problem solving tools to drive continuous improvement
- Promoted from laboratory position to quality systems due to problem solving abilities
- Assessed products or services to evaluate conformance with quality standards
- Monitored testing procedures and verified performance of tests according to established item specifications and protocol
- Developed and implemented procedures to meet product quality standards
Midwest Regional Territory Manager
Innovex, INC
Chicago, IL
02.1999 - 01.2000
- Responsible for sale of wide range of small animal and equine products to veterinarians
- Held seminars for veterinary staff on products
- Represented company at trade shows
- Met 100% of sales goals
Equine Breeding Manager
Island Farm
Elkhorn, WI
06.1998 - 01.1999
- Responsible for care, management, and breeding of 100 head sport horse farm.
- Manage team of barn staff
Education
Bachelor of Science -
08.1994 - 05.1998
Skills
Policy and Complianceundefined
Accomplishments
Purdue University Bravo Award winner for finding significant cost savings through the use of efficiency tools, and bringing laboratories back on line for testing and compliance after building flooded
Purdue Agriculture TEAM Award as a member of the Indiana Dicamba Response Team for effectively implementing validated methodology for the detection of Dicamba A.I. in the pesticide residue laboratory
Committee Chair, SFIREG Environmental Quality Issues collaborating with EPA to identify and improve testing capabilities and threshold requirements for PFAS/PFOS
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Director of Quality Management Systems - Inari
05.2021 - Current
Quality Assurance Director - Office of Indiana State Chemist, Purdue University
08.2013 - 04.2021
Quality Assurance Manager - SSCI, Inc
04.2004 - 08.2013
Technical Writer - Eli Lily & Co
10.2003 - 03.2004
Quality Systems Specialist - Abbott Laboratories
02.2000 - 07.2003
Midwest Regional Territory Manager - Innovex, INC
02.1999 - 01.2000
Equine Breeding Manager - Island Farm
06.1998 - 01.1999
Southern Illinois University Carbondale - Bachelor of Science,
08.1994 - 05.1998
Affiliations
Member, Alpha Zeta Honor Fraternity
Committee Chair, SFIREG Environmental Quality Issues
Planning Committee Member, Presenter, Pesticide Regulatory Education Program (PREP)
Designated Ethics Officer with the OIG at OISC
Primary Contact for Food Emergency Response Network (FERN), OISC
Member, AOAC
Additional Information
- Recognition and Awards , Purdue Agriculture 2018 TEAM Award as a member of the Indiana Dicamba Response Team November 7, 2018 Purdue University Bravo Award winner 2015 for finding significant cost savings through the use of efficiency tools
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